Arbutus Biopharma

Arbutus Biopharma Corporation

Company type	Public
Traded as	Nasdaq: ABUS Russell 2000 Component
Industry	Biotechnology
Founded	2007; 18 years ago (2007)
Headquarters	Vancouver, British Columbia, Canada
Products	HBV Therapies, AB-729, AB-836
Website	http://arbutusbio.com/

Arbutus Biopharma Corporation is a publicly traded Canadian (NASDAQ: ABUS) biopharmaceutical company with an expertise in liposomal drug delivery and RNA interference, and is developing drugs for hepatitis B infection.^[1]

It is headquartered in Warminster, Pennsylvania.^[2] The company was formerly known as Tekmira, which was spun out of Inex Pharmaceuticals in 2007.

History

Tekmira, as the company was formerly called, was formed as a wholly owned subsidiary of Inex Pharmaceuticals in 2005 after that company began collapsing after its regulatory and partnering strategy failed in 2004.^[3][4][5] Tekmira was fully spun out in 2007 and Tekmira absorbed the assets of Inex, which had been founded in 1992.^[5][6][7]

Inex had been developing liposomal formulations of off-patent cancer drugs, and licensed them to Talon Pharmaceuticals in 2005; Talon was acquired by Spectrum Pharmaceuticals in 2013, and three former Inex/Tekmira products reached the market and began generating royalties for Tekmira: Marqibo (liposomal vincristine), Alocrest (liposomal vinorelbine) and Brakiva (liposomal topotecan).^[8]

Inex had also acquired licenses to intellectual property, as well as staff and manufacturing facilities, concerning RNAi technology from Lynx Therapeutics in 1998;^{[4]: 10 [9]} this set of technologies became the focus for Tekmira and it initially sought to develop liposomally encapsulated RNAi drugs for a broad range of indications.^[5]

Tekmira also worked on providing liposomal delivery technology to other companies. In 2007 it signed a license agreement with Alnylam Pharmaceuticals so that Alnylam could use it to deliver its own RNAi drugs; that deal was expanded into a manufacturing agreement in 2009.^[10]

Most of those products not focused on viral diseases faltered,^[11] and Tekmira had only $6.3 million in cash when it filed suit against Alnylam in 2011 for breaching its contract and stealing trade secrets.^[10] The suit was settled in 2012, with Alnylam agreeing to pay Tekmira $65 million in termination fees, and the companies negotiated a new license agreement with lower milestones and royalties, which covers Alnylam's product patisiran.^[10][12]

Tekmira caught the world's attention and its stock rose dramatically during the 2013 West African Ebola virus epidemic due to its drug candidate for Ebola fever, TKM-Ebola.^[11] Tekmira was developing it under a $140 million US Department of Defense contract.^[13] While its stock was trading high in January 2015, it acquired OnCore BioPharma, a company focused on hepatitis B.^[14][15]

On December 19, 2014, Tekmira announced the appointment of former Bill & Melinda Gates Foundation CFO Richard Henriques to the company's board of directors. The company simultaneously announced the forthcoming departure of Ian MacLachlan as Executive Vice President and Chief Technical Officer.^[16]

Development of TKM-Ebola was terminated in mid June 2015 during a Phase II trial, for lack of efficacy.^[17][18]

The next month, Tekmira changed its name to Arbutus Biopharma and said that it would focus on drugs to treat hepatitis B.^[11][19]

In March 2017 Arbutus signed another license for its liposome delivery technology, this time with Alexion Pharmaceuticals, for delivery of an mRNA drug candidate.^[12] This license was terminated in July 2017, when Alexion discontinued preclinical programs outside its core complement franchise.^[20]

In 2019, Arbutus began a phase 1 clinical study using AB-506 to treat chronic hepatitis B. The company released preliminary data in July and stopped the trial in October after two patients developed acute hepatitis.^[21] Now AB-729 is paving the way for Arbutus, as they recently received the FDA go ahead to pursue phase 2 trials, after having their data voted best in ILC, 2021; after abandoning development of previous investigational agents. AB-836, their next generation capsid inhibitor, is now also showing great promise against mutants, in its Phase 1 trials.

In July 2019, Arbutus Biopharma announced the sale of part of its royalty interest on future global net sales of ONPATTRO, an RNA interference therapeutic currently sold by Alnylam Pharmaceuticals, to OMERS for $20 million.^[22]

COVID-19

On March 10, 2023, U.S. District Judge Mitchell Goldberg rejected a bid by Moderna to dismiss some of the patent infringement claims brought against the company by Arbutus and its partner, Genevant Sciences.^[23]

References

1. "Arbutus' hepatitis B drug shows Phase 2 promise". BioPharma Dive. Retrieved 2019-01-25.
2. George, John (August 19, 2016). "Major tenant leaving Pa. Biotechnology Center for more space in Warminster". Philadelphia Business Journal.
3. "Inex Pharmaceuticals slashes more staff as CEO departs". CBC News. June 21, 2005.
4. "Inex 2004 Annual Report". Inex Pharmaceuticals.
5. "Tekmira Annual Report on Form 20-F For the fiscal year ended December 31, 2010". www.sec.gov. Tekmira via SEC Edgar. 3 June 2011. p. 19.
6. "Press Release: Inex Pharmaceuticals Announces Completion of Spin-out of Tekmira Pharmaceuticals Corporation". Inex via Newswire.ca. 1 May 2007.
7. "Inex Pharmaceuticals Corp". LifeSciencesWorld. Retrieved 9 May 2017.
8. "Tekmira Provides Update on Licensed Product Candidate, Marqibo(R)". GlobeNewswire. 18 July 2013. Retrieved 12 March 2021.
9. Hitt, Michael A.; Harrison, Jeffrey S.; Ireland, R. Duane (2001). Mergers & Acquisitions: A Guide to Creating Value for Stakeholders. Oxford University Press. p. 138. ISBN 9780195354560.
10. Zimmerman, Luke (12 November 2012). "Alnylam to Pay Tekmira $65M to Settle RNAi Delivery Dispute". Xconomy.
11. Garde, Damian (July 20, 2015). "Tekmira changes its name and shuffles away from Ebola". FierceBiotech.
12. "Triple A: Arbutus on road to further deals with LNP after $82M Alexion tie-up". BioWorld. March 20, 2017.
13. Atkins, Richard (9 August 2014). "Biotech Stock in Spotlight: As the World Awaits Ebola Treatment, Tekmira Pharma In Prime Focus". TechNews. Retrieved 10 August 2014.
14. "Tekmira and OnCore Tie the Knot, Plan to Focus on HBV Treatment". Genetic Engineering & Biotechnology News. January 12, 2015.
15. Saxena, Varun (January 14, 2015). "Tekmira stock soars on acquisition of OnCore to strengthen hep B pipeline". FiercePharma.
16. Rezler, Julie P. (2014-12-19). "Tekmira Pharmaceuticals Announces Leadership Changes". Securities and Exchange Commission. Archived from the original on 2023-06-01. Retrieved 2023-06-01.
17. Pollack, Andrew (2015-06-19). "Clinical Trial of Experimental Ebola Drug Is Halted". The New York Times. ISSN 0362-4331. Retrieved 2017-05-08.
18. "In setback for potential Ebola drug, company halts trial". Science. 2015-06-19. Retrieved 2017-05-08.
19. George, John. "Bucks County researchers in hunt for hepatitis B cure". Philadelphia Business Journal.
20. "Alexion (ALXN) Redefines R&D Strategy, Discontinues Programs and Kills Deals With Moderna, Blueprint (BPMC) and Arbutus Biopharma (ABUS)". BioSpace. July 27, 2017.
21. "Arbutus cans early-phase hep B program after 2 healthy people fall ill". FierceBiotech. 4 October 2019.
22. Liu, Ted (2019-07-02). "OMERS acquires partial ONPATTRO royalty streams from Arbutus for US $20M". Private Capital Journal. Archived from the original on 2023-06-04. Retrieved 2020-03-12.
23. Brittain, Blake (2023-03-10). "Moderna loses bid to shift liability in COVID-19 vaccine patent case". Reuters. Archived from the original on 2023-03-11. Retrieved 2023-08-25.

External links

• Official website